Comparison of efficacy and safety of oral corticosteriod mini pulse versus oral tofacitinib in stabilization and repigmentation of active vitiligo: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- A.Arrest of disease progression (clinical and dermoscopic assessment)
研究概览
简要总结
Recruitment yet to commence
By this trial we would compare efficacy and safety of oral corticosteroid mini pulse versus oral tofacitinib in stabilization and repigmentation of active vitiligo
Trial not yet started
PROCEDURE:
After informed written consent, Patients will be enrolled in the study based on the inclusion criteria and exclusion criteria. The patients demographic details, disease duration, sites of involvement and previous treatment history, clinical examination will be recorded. Morphology and distribution of vitiligo lesions will be documented in the body chart. Patients will be evaluated for vitiligo skins lesions. Baseline investigations like CBC, KFT, LFT, CHEST XRAY, plasma glucose fasting , glycosylated haemoglobin, ECG, urine R/M, fasting lipid profile, UPT(in females), screening for HIV, hepatitis B and C and serum IL6 levels will be done.
Dermoscopy findings will be recorded on representative vitiligo lesion. Patient will be asked to fill the Dermatology life quality index (VIS 22). VASI will be calculated. Patient who fulfilled the selection criteria will be randomly allocated to one of the two groups for a treatment duration of 24 weeks.
GROUP A - Patients will receive OMP 5 mg on 2 consecutive days/week for 16 weeks or till VIDA score of 3+, whichever is earlier. To be tapered till total duration of 24 weeks. Tapering shall not be done if arrest of disease progression is not achieved. Oral calcium-vitamin D3 supplementation shall be advised. Symptomatic treatment for any other side effects shall be done. GROUP B - Patients will receive tofacitinib 5 mg OD for 2 weeks followed by 5 mg BD for 14 weeks or till VIDA score of 3+, whichever is earlier. To be tapered till total duration of 24 weeks. Tapering shall not be done if arrest of disease progression is not achieved. Symptomatic treatment for any other side effects shall be done.
Serum IL-6 levels shall be done in all patients at baseline as well as post treatment, that is, at 24 weeks. A group of stable vitiligo patients (no disease activity for past >3 months) shall be recruited as controls for serum IL-6 estimation.
FOLLOW UP
First follow up at 2 week and then every 4 weekly. Plan to taper the therapy if disease arrest of disease progression for 1 month, otherwise same dose shall be continued.
Blood investigations will be group specific and shall be repeated as follows:
Group A – Fasting blood sugar at 0,4 and 24 weeks (any other time frame if abnormal). HbA1c at 0 and 24 weeks.
Group B – CBC at 0,2,4,12 and 24 weeks (any other time frame if abnormal). Fasting lipid profile at 0,4 and 24 (any other time frame if abnormal). LFT at 0,4,12 and 24 weeks.
Follow up visits –
Clinical examination, clinical photography, dermoscopy: 4 weekly
Investor global assessment (IGA)/ Vitiligo area scoring index (VASI) 4 weekly
Patient global assessment(PGA): 4 weekly
Vitiligo disease activity score (VIDA): 12 ,16 and 24 weeks
Serum IL6 levels : 0 and 24 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •All consecutive patients with body weight >35 kg and age < 50 years, of either gender who are willing to participate and fulfill the following eligibility criteria for active vitiligo: 1.Subjects with non-segmental, unstable vitiligo with body surface area involved >2% 2.Disease activity in the past 3 months – a.New lesions b.Increase in the size of the older lesions c.Depigmentation of previously repigmented lesions.
排除标准
- •Patient having any of the following criteria will be excluded from the study.
- •1.Segmental vitiligo 2.Pregnancy or lactation 3.Presence of any of the following: immunocompromised host, malignancy, co-morbidities like uncontrolled diabetes, renal disease, hepatitis.
- •4.Any known contraindication or hypersensitivity to any of the study molecules.
结局指标
主要结局
A.Arrest of disease progression (clinical and dermoscopic assessment)
时间窗: 2, 4, 8, 12, 16, 20, 24 weeks
1. No new lesions.
时间窗: 2, 4, 8, 12, 16, 20, 24 weeks
2. No increase in the size of the older lesions.
时间窗: 2, 4, 8, 12, 16, 20, 24 weeks
3. No depigmentation of previously repigmented lesions
时间窗: 2, 4, 8, 12, 16, 20, 24 weeks
B.Improvement in the vitiligo signs of activity score37 (VSAS) score from baseline.
时间窗: 2, 4, 8, 12, 16, 20, 24 weeks
次要结局
- A.Repigmentation :(a. Objective - Investor global assessmen39 (IGA) and Vitiligo area scoring41(VASI))